OWD · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
OWD
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
PA
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
The somatic gene mutation detection system is an in vitro diagnostic nucleic acid amplification and real-time detection system for the identification of genetic mutations in DNA extracted from human tumor tissues.